SIMETHICONE CAPSULES 250 mg, liquid filled

Manufacturer: ONE2ZEE LIMITED LIABILITY COMPANY | Medgel Private Limited
Effective date: 2023-03-25
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:54:33

Label at a glance#

ProductSimethicone

Active ingredientDIMETHICONE

Label structure8 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

store at room temperature 59°-86°F (15°-30°C

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

STORAGE AND HANDLING SECTION

store at room temperature 59°-86°F (15°-30°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, sorbitol, fd&c blue no. 1, fd&c red no. 40, povidone k30, titanium dioxide, water

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Simethicone capsules

Each Softgel Contains:
(Simethicone 250mg)

LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-017-
EXP DATE:

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.

Shipper label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
412111	simethicone 250 MG Oral Capsule	PSN	2
412111	simethicone 250 MG Oral Capsule	SCD	2
412111	dimethicone 250 MG Oral Capsule	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55629-017-01	2025-01-30	C162847	48780-1	f386c649-bf08-0266-e053-dadaa90a7c1a	SIMETHICONE CAPSULES 250 mg, liquid filled
55629-017-01	2023-03-25	C162847	48780-1	f386c649-bf08-0266-e053-dadaa90a7c1a	SIMETHICONE CAPSULES 250 mg, liquid filled
55629-017-01	2023-01-30	C162847	48780-1	f386c649-bf08-0266-e053-dadaa90a7c1a	SIMETHICONE CAPSULES 250 mg, liquid filled

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55629-017-01	Simethicone	48 in 1 CARTON	CAPSULE, LIQUID FILLED	48		2
55629-017-02	Simethicone	1500 in 1 POUCH	CAPSULE, LIQUID FILLED	1500		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55629-017	SIMETHICONE CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY]	2	Legacy NDC, 2 package rows	20230326_3292fe8e-a41a-4890-baf2-575752704a48.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Simethicone
DIMETHICONE
GELATIN
GLYCERIN
SORBITOL
FD&C BLUE NO. 1
D&C RED NO. 33
Povidone K30
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55629-017	55629-017-02, 55629-017-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
SORBITOL	506T60A25R	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
Povidone K30	U725QWY32X	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2385d841-0306-4b08-9f9d-0e66283de312			3292fe8e-a41a-4890-baf2-575752704a48	2023-03-25	Warnings	Exact identifier spl id: 2385d841-0306-4b08-9f9d-0e66283de312 spl set id: 3292fe8e-a41a-4890-baf2-575752704a48

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.